Objectives To assess the effectiveness and safety of risperidone and aripiprazole in children with autism spectrum disorder (ASD).
Design and setting Overview of systematic reviews (SRs).
Search methods In October 2021, we searched Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycInfo and Epistemonikos placing no restrictions on language or date of publication.
Participants Children aged 12 years or less with ASD.
Interventions Risperidone and aripiprazole with no dosage restrictions.
Data collection and analysis We rated the methodological quality of the included SRs using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2). We reported the Grading of Recommendations, Assessment, Development and Evaluation certainty of the evidence according to the analysis conducted by the authors of the included SRs.
Main outcomes measured A multidisciplinary group of experts agreed on analysing nine critical outcomes evolving core and non-core ASD symptoms.
Patient and public involvement Organisations of parents of children with ASD were involved during part of the process, participating in external revision of the final version of the report for the Chilean Ministry of Health with no additional comments (ID 757-22-L120 DIPRECE, Ministry of Health, Chile). The organisations involved were: Fundación Unión Autismo y Neurodiversidad, Federación Nacional de Autismo, Vocería Autismo del Sur, and Vocería Autismo del Norte.
Results We identified 22 SRs within the scope of this overview, of which 16 were of critically low confidence according to AMSTAR 2 and were excluded from the analysis. Both aripiprazole and risperidone were effective for reducing autism symptoms severity, repetitive behaviours, inappropriate language, social withdrawal and behavioural problems compared with placebo. The certainty of the evidence for most outcomes was moderate. Risperidone and aripiprazole are associated with metabolic and neurological adverse events. Follow-up was short termed.
Conclusions We found that aripiprazole and risperidone probably reduce symptom severity at short-term follow-up but may also cause adverse events. High-quality and updated SRs and larger randomised controlled trials with longer term follow-up are needed on this topic.
Overview protocol PROSPERO CRD42020206535.
- prescription drugs
- nervous system diseases
Data availability statement
Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author on reasonable request and at our OSF registry (https://osf.io/aedxj/).
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Twitter @micaelaescb, @nicolasmezac
Contributors All authors have contributed significantly to this manuscript and agree with its content. Study concept and design—JVAF, EM, NM, VR and CME-L. Acquisition of data—CME-L, NM and EM. Analysis/interpretation of data—all authors. Drafting of the article—CF, MC, NM, JVAF and CME-L. Revision of article—all authors. JVAF will be the guarantor of the study.
Funding In an effort to address the sizeable needs of this neglected population group, the Chilean Ministry of Health (MINSAL) commissioned a group of researchers from Universidad de Valparaíso to prepare a manual for a comprehensive approach to autism spectrum in children up to the age of 12 years, based on an investigation of SR that included pharmacological and/or non-pharmacological therapies available in our country. Department of Mental Health, Chilean Ministry of Health, Grant ID 757-22-L120.
Competing interests None declared.
Patient and public involvement statement Patients or the public were involved in the design, or conduct, or reporting, or dissemination plans of our research.
Provenance and peer review Not commissioned; externally peer reviewed.
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